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June 3, 2024 Agency Capture Health Conditions News

Agency Capture

Health Officials Push Mpox Vaccine After Bavarian Nordic’s FDA-Approved Shot Hits Commercial Market

Until last month, the federal government distributed the Jynneos vaccine — the only mpox vaccine approved in the U.S. — for free. Now that Bavarian Nordic’s vaccine is commercially available, providers can bill insurance companies for the shots.

monkey pox vaccine with money

Mpox (formerly “monkeypox”) disease is in the news again — from concerns over Pride Month celebrations to outbreaks in the U.S., Australia and South Africa — prompting public health officials to promote the mpox vaccine.

While authorities maintain vaccination is crucial for protecting high-risk communities, some question whether the renewed push is warranted — and whether the recent commercialization of Bavarian Nordic‘s Jynneos vaccine is behind the latest push.

Dr. Meryl Nass, an internist and biowarfare expert, noted on her Substack last week that until last month, the federal government distributed the Jynneos vaccine — the only mpox vaccine approved in the U.S. — for free.

Since Bavarian Nordic announced on April 2 that the vaccine is now commercially available, providers can now bill insurance companies for the shots.

Nass noted that mpox cases have dramatically declined since the 2022 outbreak, with Oregon reporting just 30 cases in 2023 and eight cases as of April 2024, with no deaths.

Yet, the Oregon Health Authority (OHA) issued a news release last week encouraging mpox vaccination.

And on May 24, the World Health Organization, which reported 528 confirmed mpox cases and one death in 27 countries as of April, released a “strategic framework for enhancing prevention and control of mpox,” which recommended “efforts to improve access to vaccines.”

However, Washington state’s guidance on home mpox care implies most cases are mild and manageable without hospitalization, Nass pointed out.

“So why would state health departments encourage this vaccine when there have been few cases in Oregon and the disease is mild?” Nass asked. “Because the monkeypox vaccine just entered the commercial market. Money is now on the table, where it wasn’t, before.”

Dr. Lynn Fynn weighed in on the bird flu and mpox scares on X (formerly known as Twitter):

Vaccination can lead to breakthrough infections

The OHA press release noted that mpox spreads primarily through skin-to-skin contact and most often through intimate or sexual contact.

Infection also can occur from “contact with the lesions of an individual with mpox through a caregiving relationship, such as a parent caring for a child or an adult caretaker of another person.”

“The JYNNEOS mpox vaccine is highly effective,” the OHA announcement continued, citing a study published in the Centers for Disease Control and Prevention’s (CDC) May Morbidity and Mortality Weekly Report showing the vaccine to be “75% effective for those receiving one dose and 86% effective for those who had two doses.”

However, that same study also stated that “infection in fully vaccinated persons can occur.”

The study reported that 271 monkeypox cases (less than 1%) occurred among fully vaccinated individuals between May 2022 and May 2024 and that the infections were less severe compared to unvaccinated cases.

However, a 2022 CDC study reported a higher incidence of breakthrough infections, finding that among 9,544 mpox cases reported in men ages 18-49, 1,224 (12.8%) occurred in vaccinated persons.

Nass, in a Brownstone Institute article in August 2023, noted that Jynneos failed to prevent infection in its trials with monkeys.

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Jynneos may cause myocarditis, other diseases

The U.S. Food and Drug Administration (FDA) in September 2019 approved the Jynneos vaccine for the prevention of both mpox and smallpox and added it to the Strategic National Stockpile.

However, according to Nass, FDA reviewers noted the cardiac side effects of the vaccine in some of the clinical trials:

“Up to 18.4% of subjects in 2 [of 22] studies developed post-vaccination elevation of troponin [a cardiac muscle enzyme signifying cardiac damage]. However, all of these troponin elevations were asymptomatic and without a clinically associated event or other sign of myopericarditis. …

“The applicant has committed to conduct an observational, post-marketing study … The sponsor will collect data on cardiac events that occur and are assessed as a routine part of medical care.”

Nass noted that the only way to cause an elevated troponin level is to break down cardiac muscle cells. When the FDA approved the Jynneos vaccine, she said the agency did not require a specific study to evaluate the extent of cardiac damage the vaccine might cause.

In October 2023, the CDC said data from the 2022-2023 mpox outbreak reported in the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink showed that observed rates of myocarditis or pericarditis were “consistent with expected background rates.” However, the agency admitted that “the possibility of a small risk cannot be excluded.”

The Jynneos product label, under “postmarketing experience,” lists myocarditis, pericarditis and hypersensitivity reactions (including angioedema, rash and hives), among other reported symptoms.

The label also reports that for trial participants who never received the smallpox vaccine, 1.3% (95/7,093) of Jynneos recipients reported cardiac adverse events of special interest (AESIs). In comparison, just 0.2% (3/1,206) of placebo recipients reported such events.

For those who had previously received the smallpox vaccine, cardiac AESIs from the Jynneos vaccine occurred at a rate of 2.1% (16/766).

The label also reports on other serious health effects of the vaccine: “Across all studies, a causal relationship to Jynneos could not be excluded for 4 SAEs [serious adverse events], all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness.”

Dr. Peter McCullough recently warned about the mpox vaccines on X. “The Bavarian Nordic Monkeypox vaccine causes myocarditis and is not worth the risk for this low prevalence, avoidable, and easily manageable condition.”

The Biden administration in August 2022 announced that under its Administration for Strategic Preparedness Response program, it would add 5.5 million additional vials of the Jynneos vaccine to the national stockpile, providing up to 25 million doses.

At the time of the announcement, the U.S. Department of Health and Human Services had distributed more than 670,000 vaccine doses in response to the 2022 mpox outbreak.

Bavarian Nordic’s recent announcement of the commercial launch of Jynneos noted that the CDC estimates 2 million people in the U.S. are eligible for mpox vaccines, of which 60% remain unvaccinated.

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